Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 33 人开始时间: 2024年4月2日最近更新: 2024年3月28日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Centre Hospitalier Universitaire de Besancon
入组人数: 33
主要终点: Tumor antigen specific T-cell responses

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
•For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
•Written informed consent

排除标准

•History of TURBT for a bladder tumor whatever the stage
•Stages N1-3 or M1 on initial assessment
•Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
•History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
•HIV, hepatitis C or B infection
•Patients with any medical or psychiatric condition or disease,
•Patients under guardianship, curatorship or under the protection of justice.

结局指标

主要结局

Tumor antigen specific T-cell responses

时间窗: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)

Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline.

次要结局

Monitoring of immune cell death parameters in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Transcriptomic analysis(At baseline)
Monitoring of T cells in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Local progression-free survival(date of first local progression of the disease (within 2 year after the initiation of the treatment))
Monitoring of immune suppressive cells in the blood(15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C))
Progression-free survival(date of first progression of the disease (within 2 year after the initiation of the treatment))
Overall survival(Date of death from any cause (within 2 years after the initiation of the treatment))

研究者

发起方

Centre Hospitalier Universitaire de Besancon

申办方类型

Other

责任方

Sponsor

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